The PharmaCertify™ Team

Break out the white pants and seersucker suits! Its Memorial Day weekend, and summer has unofficially started! Woo hoo! It’s time to take the cover off the pool, fire up the barbeque and get our lazy, hazy summer days on! If you’re reading this, you’re probably in the same boat as us – watching the clock tick ever more slowly to the start of the weekend. Because we care about you, our dear readers, here’s a bit of something to read to pass the time. Without further adieu, this week’s News Week in Review!

So let’s dive right in with a fun little summer read. Good news for the coffee lovers out there. (Let’s face it we’ll all be downing this delicious nectar today as we wait on the clock to mercifully strike 5:00.) Turns out that all that coffee may help you live longer. A study funded by AARP and the National Cancer Institute (and Starbucks)  found that adults 50-71 who consumed two to three cups of coffee a day had a 10% lower risk of death. While the study’s lead author isn’t recommending people go out and start consuming coffee based on the results of the study, the study should make people feel better about consuming coffee (and buying stock in Starbucks).

Okay, onto more serious stuff. Developments related to the FDA user fees bill came crashing onto the beach like waves during high tide this week. The bill was introduced into the Senate early in the week and the amendments were flying fast and furious. First, Senator Orin Hatch of Utah introduced an amendment to repeal the upcoming medical device tax. Then just as quickly, Senator Dan Coates, a co-sponsor of the amendment, announced the amendment would be withdrawn, and that Senator Hatch intended to address the repeal of the tax in “another vehicle.”  Adding an amendment of his own was Senator Bernie Sanders of Vermont. That amendment would cause a pharmaceutical company to lose its product exclusivity if it were “found at fault for fraud involving a particular drug.” In a press release, Sanders cited case after case of incidences involving pharmaceutical companies and healthcare fraud, and said companies that defraud Medicare and Medicaid, or illegally market drugs, should not enjoy the government-provided monopoly for those drugs. Oddly enough, Senator Sanders was the odd-man out when the Senate passed the bill on Thursday with a 96-1 vote.

And you thought getting your brother-in-law to switch from charcoal to a gas grill was tough! A new study finds that physicians who limit contact with, or do not see, drug sales representatives are more likely to continue to prescribe drugs with a black box warning over newer therapies. The study found physicians with restricted access to drug sales representatives were four times less likely to move from a drug with a black box warning to a best in class drug than their peers without such restrictions. The study’s lead author says the increase of access restriction had an effect on physicians’ decision making beyond what is anticipated by healthcare systems and large group practices.

The OIG posted a video and transcript of the keynote address delivered by Inspector General Daniel R. Levinson to the Healthcare Compliance Association’s Compliance Institute. Mr. Levinson opened by commenting about the HCCA survey that revealed six out of ten compliances officers lose sleep over their job. He said he didn’t mind the bad guys stressing over doing the wrong thing, but he knew this audience was filled with the good guys. The Inspector General used a handy acronym to discuss the areas covered by the OIG – EPCOR (um…shouldn’t that be EPCOT?) enrollment, payment, compliance, oversight and remediation. He went on to explain the OIG’s role for each of these. He also covered the OIG’s enforcement authorities and social media presences.

Things are starting to heat up in the House of Representatives regarding Wal-Mart’s foreign bribery fiasco. Democrat House members have sent letters to the U.S. Chamber of Commerce and the Retail Industry Leaders Association (RILA) requesting information about Wal-Mart’s involvement in the lobbying effort for FCPA reform. The House members believe there are conflicts of interest in Wal-Mart being involved in a lobbying effort for reform of the FCPA while they were in the midst of an internal investigation for possible FCPA violations. The lobbying efforts were headed by the Chamber’s Institute for Legal Reform (ILR), and Wal-Mart has a representative on the Institute’s board of directors. Lawmakers have requested minutes of meetings from ILR’s board meetings.

The bribery pool is seeing an increase of folks swimming about. A survey by Ernst and Young finds that the number of top executives willing to pay a bribe to get or keep business increased 6 percent this year. Ernst and Young says top managers are underestimating the risk as they expand into new markets. The findings are particularly concerning due to the level of responsibility for the individuals involved.

Well folks, we’re a few ticks of the clock closer to the weekend. We’ll leave you with one last story to consider as you make your plans for the weekend. The FDA has pushed back the new labeling requirements for sunscreen six months. By my count, that puts us squarely in winter.

Have a safe and enjoyable weekend everyone!